CLINICAL TRIALS PROFILE FOR MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4

505(b)(2) Clinical Trials for Multiple Electrolytes Injection Type 1 Usp Ph 7.4

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00490932 ↗	New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management- Surveillance Study for Adverse Effects	Completed	Society for Applied Studies	Phase 4	2005-03-01	For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
New Formulation	NCT00627796 ↗	Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly	Completed	University of Genova	Phase 4	2003-01-01	Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
New Formulation	NCT00627796 ↗	Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly	Completed	Federico II University	Phase 4	2003-01-01	Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
New Formulation	NCT02909036 ↗	Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.	Active, not recruiting	Spectrum Pharmaceuticals, Inc	Phase 1	2016-09-01	Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan chemotherapy that in packaged in an inactive substance that is believed to help the chemotherapy be more stable (meaning that it doesn't lose its effect or need to be administered quickly after being mixed). It may also have fewer side effects such as problems with important levels of body electrolytes such as potassium, phosphorous and magnesium; and cause less kidney and heart damage] than standard formulation melphalan. The purpose of this study is to determine if the investigators can achieve a certain level of Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL Amyloidosis.

All Clinical Trials for Multiple Electrolytes Injection Type 1 Usp Ph 7.4

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University Medical Center	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00004328 ↗	Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I	Completed	University of Texas	Phase 2	1992-12-01	OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00004328 ↗	Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I	Completed	National Center for Research Resources (NCRR)	Phase 2	1992-12-01	OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00004360 ↗	Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus	Completed	Northwestern University		1995-09-01	OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.

Clinical Trial Conditions for Multiple Electrolytes Injection Type 1 Usp Ph 7.4

Condition Name

Condition Name for Multiple Electrolytes Injection Type 1 Usp Ph 7.4
Intervention	Trials
Schizophrenia	11
Heart Failure	9
Hypertension	9
Healthy	8

Condition MeSH

Condition MeSH for Multiple Electrolytes Injection Type 1 Usp Ph 7.4
Intervention	Trials
Syndrome	22
Heart Failure	20
Hypertension	15
Kidney Diseases	14

Clinical Trial Locations for Multiple Electrolytes Injection Type 1 Usp Ph 7.4

Trials by Country

Trials by Country for Multiple Electrolytes Injection Type 1 Usp Ph 7.4
Location	Trials
United States	344
Canada	37
China	35
United Kingdom	34
Egypt	25

Trials by US State

Trials by US State for Multiple Electrolytes Injection Type 1 Usp Ph 7.4
Location	Trials
Texas	39
New York	32
California	27
Maryland	22
Pennsylvania	20

Clinical Trial Progress for Multiple Electrolytes Injection Type 1 Usp Ph 7.4

Clinical Trial Phase

Clinical Trial Phase for Multiple Electrolytes Injection Type 1 Usp Ph 7.4
Clinical Trial Phase	Trials
Phase 4	114
Phase 3	59
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for Multiple Electrolytes Injection Type 1 Usp Ph 7.4
Clinical Trial Phase	Trials
Completed	211
Recruiting	55
Terminated	46

Clinical Trial Sponsors for Multiple Electrolytes Injection Type 1 Usp Ph 7.4

Sponsor Name

Sponsor Name for Multiple Electrolytes Injection Type 1 Usp Ph 7.4
Sponsor	Trials
University of North Carolina, Chapel Hill	8
University of Maryland	8
Baylor College of Medicine	8

Sponsor Type

Sponsor Type for Multiple Electrolytes Injection Type 1 Usp Ph 7.4
Sponsor	Trials
Other	659
Industry	115
NIH	31

Multiple Electrolytes Injection, Type 1, USP, pH 7.4: Clinical Trials, Market Analysis, and Projections

Introduction

Multiple Electrolytes Injection, Type 1, USP, pH 7.4, is a sterile, nonpyrogenic isotonic solution used intravenously as a source of water, electrolytes, and calories, or as an alkalinizing agent. Here, we will delve into the clinical trials, market analysis, and future projections for this essential medical product.

Clinical Trials and Safety Profile

Clinical Trials Overview

Clinical trials for Multiple Electrolytes Injection, Type 1, USP, pH 7.4, have primarily focused on its efficacy and safety as a parenteral solution. These trials have been conducted to assess its role in various clinical conditions, including fluid and electrolyte imbalances, metabolic acidosis, and as a component in blood transfusions.

Adverse Reactions

The safety profile of Multiple Electrolytes Injection includes several reported adverse reactions. These include hypersensitivity and infusion reactions such as tachycardia, chest pain, dyspnea, flushing, and hyperemia. Other adverse effects include infusion site pain, hyperkalemia, hyponatremia, and in severe cases, hyponatremic encephalopathy[2][3][4].

Postmarketing Reports

Postmarketing reports have also highlighted the importance of careful administration to avoid fluid and solute overloading, which can lead to complications such as peripheral and pulmonary edema, especially in patients with impaired renal function[2][3][4].

Market Analysis

Market Demand

The demand for Multiple Electrolytes Injection, Type 1, USP, pH 7.4, is driven by its versatility and critical role in managing various medical conditions. It is widely used in hospitals, clinics, and other healthcare settings for patients requiring intravenous fluid and electrolyte replacement.

Market Size and Growth

The global market for parenteral solutions, including Multiple Electrolytes Injection, is expected to grow significantly due to increasing healthcare needs, an aging population, and advancements in medical technology. The market size is projected to expand as more healthcare facilities adopt these solutions for patient care.

Competitive Landscape

The market for Multiple Electrolytes Injection is competitive, with several manufacturers such as Fresenius Kabi and Baxter International offering similar products. However, the specific formulation and compatibility with blood components make Multiple Electrolytes Injection, Type 1, USP, pH 7.4, a preferred choice in many clinical settings[3][4].

Market Projections

Future Trends

The future of Multiple Electrolytes Injection, Type 1, USP, pH 7.4, looks promising with several trends driving its growth:

• Increasing Use in Critical Care: The solution is likely to see increased use in intensive care units (ICUs) and emergency departments due to its efficacy in managing critical fluid and electrolyte imbalances.
• Advancements in Formulation: Ongoing research may lead to improved formulations that reduce the risk of adverse reactions and enhance patient outcomes.
• Growing Demand in Emerging Markets: As healthcare infrastructure improves in emerging markets, the demand for parenteral solutions like Multiple Electrolytes Injection is expected to rise.

Regulatory Environment

Regulatory updates and guidelines will continue to play a crucial role in the market for Multiple Electrolytes Injection. For instance, the FDA's ongoing monitoring of postmarketing safety data ensures that any new safety concerns are promptly addressed, which can impact market dynamics[5].

Key Considerations for Healthcare Providers

Administration Guidelines

Healthcare providers must adhere strictly to administration guidelines to avoid complications such as air embolism and fluid overload. This includes using sterile equipment, inspecting the solution for particulate matter, and avoiding connections that could lead to air embolism[3][4].

Patient Monitoring

Regular monitoring of fluid balance, electrolyte concentrations, and acid-base balance is essential during prolonged parenteral therapy. This helps in early detection and management of any adverse effects[4].

Key Takeaways

• Clinical Use: Multiple Electrolytes Injection, Type 1, USP, pH 7.4, is a valuable source of water, electrolytes, and calories, and it also serves as an alkalinizing agent.
• Safety Profile: The solution has a defined safety profile with potential adverse reactions that require careful monitoring.
• Market Growth: The market for this product is expected to grow driven by increasing healthcare needs and advancements in medical technology.
• Regulatory Compliance: Adherence to regulatory guidelines and ongoing safety monitoring are crucial for its continued use.

FAQs

What is Multiple Electrolytes Injection, Type 1, USP, pH 7.4 used for?

Multiple Electrolytes Injection, Type 1, USP, pH 7.4, is used as a source of water and electrolytes or as an alkalinizing agent.

What are the common adverse reactions associated with Multiple Electrolytes Injection?

Common adverse reactions include hypersensitivity and infusion reactions, infusion site pain, hyperkalemia, hyponatremia, and in severe cases, hyponatremic encephalopathy.

Can Multiple Electrolytes Injection be used with blood components?

Yes, it is compatible with blood or blood components and can be administered prior to, following, or concurrently with blood transfusions.

What are the risks of excessive administration of Multiple Electrolytes Injection?

Excessive administration can cause fluid overload, hypernatremia, hyperkalemia, and metabolic alkalosis, particularly in patients with severe renal impairment.

How should Multiple Electrolytes Injection be administered to avoid complications?

It should be administered using sterile equipment, with careful inspection for particulate matter, and avoiding connections that could lead to air embolism.

Sources

1. DailyMed: VETERINARY PLASMA-LYTE A - DailyMed
2. DailyMed: Multiple Electrolytes Injection, Type 1, USP, pH 7.4 in FREEFLEX ...
3. Fresenius Kabi: Multiple Electrolytes Injection, Type 1, USP, pH 7.4
4. RxList: Plasma-Lyte A - Multiple Electrolytes Injection - RxList
5. FDA: NDA 17378/S-075 - accessdata.fda.gov